9 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electric wheelchair (C001)
FDA 510(k)
FDA Class 2
·Physical Medicine
NA
FDA UDI
Medos International Sàrl·10886705031986·4K EP Arthroscope/Sinuscope compatible with Mit...
SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCUCATH MIDLINE CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 28, 2023
CORAIL2 STD SIZE 10
FDA Adverse Event
Injury
·DEPUY FRANCE SAS-3003895575·Product code KWA·November 10, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 9, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
PKG, 5MM INSERT, PARK FORCEPS, P/N 0250080733 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014